Anna E. Email & Phone Number

Cork, County Cork, Ireland

Cork, Ireland

Initiation investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, communication with ERB and Competent Authority, customizing the country budget, site budgets negotiation and contract signing, tracking and facilitating site compliance to required training, and driving timelines effectively aligned with company priorities;Communication directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out;Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems;As a Primary Point of Contact for Associate within the EU region:Liaising with Global study team and country teams to define and implement the initial strategy for submissions within the regionPrepare, in consultation with global study team EUCTA application formOversight about progress on trial capabilities activities in the region including supporting in identifying trial risks.

Moscow, Russian Federation

• Responsible for all project management activities in preclinical and clinical studies required for Marketing Authorization of the company’s medicinal products in the Russian Federation: creation of the essential study documents, contract and budget negotiation with CRO’s and other Vendors, RA and EC approvals obtaining, co-monitoring activities, TMF maintenance, clinical study report finalization and submission to RA, study archiving;• Responsible for keeping all clinical deliverables of the clinical studies within agreed timelines and budget;• Keep high standards of quality in clinical trials and ensure that all activites are performed according to the company’s SOPs, working instructions and all applicable regulatory requirements;• Participation in quality management system’s maintenance: SOPs’ creation / revision, participation in internal / external audits, CAPAs implementation.

Moscow, Russian Federation

• Responsible for all aspects of project management activities from the study initiation till the close-out for the assigned protocols;• Feasibility work for new requests from the Sponsors or CRO;• Preparing the essential documents for the study start;• Negotiation and signing the study contract / budget with the Sponsors and CRO;• Initial training of the CRA’s and site staff at the Investigators’ meeting;• Ensuring all essential data are entered into Informational system of the Clinical trials on time;• SOPs’ generation and participation in quality management system’s improvement;• participation in internal and external audits;• conducting the audits of the Vendors.

Moscow, Russian Federation

09.2014 - 07.2015 - Clinical research associated II02.2012 - 09.2014 - Clinical research associated I09.2010 - 02.2012 - Clinical research assistant· Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned· Responsible for all aspects of site management as prescribed in the project plans· General On-Site Monitoring Responsibilities· Prepare accurate and timely trip reports· Responsible for all aspects of registry management as prescribed in the project plans· Undertake feasibility work when requested· Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor· Negotiate study budgets with potential investigators· Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs· SUSARs, DSUR and PSUR submission to RA· Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management· Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned· Perform other duties as assigned by management

Moscow, Russian Federation

• conducting routine laboratory examination• assuring quality of the analytical process• carrying out scientific work

Specialist, Internship In Pharmaceutical Chemistry

Pharmacy